PoliomyelitisPhase 1IPVNCT01048190

The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

A Phase 1 study testing Inactivated Poliomyelitis Vaccine (Sabin strains) in people with Poliomyelitis, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. Read more about this study

Who is it for?: Ages 60 to 90 daysHealthy volunteers can take part
Conditions the study is for: Poliomyelitis
What is being tested?: Inactivated Poliomyelitis Vaccine (Sabin strains)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteChina
Study dates: Aug 2008to Mar 2009
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 90 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Males and females, age from 60 days to 60 years old;
Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
Axillary temperature ≤37℃.

Who cannot join

Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
Low platelet or bleeding disorder do not allow vaccination into the muscle;
Have damaged or lower immunological function;
Received blood, plasma or immunoglobulin treatment since birth;
Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ).

Trial locations and contacts

1 site in 1 country.

China1 site

Hezhou Center for Disease Prevention and Control
Hezhou, Guangxi, 542800

Other trials in China

About this study

Official title: The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Read the detailed description

The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Conditions: Poliomyelitis
Being tested: Inactivated Poliomyelitis Vaccine (Sabin strains)
Keywords: Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis
Medical subject headings: Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inactivated Poliomyelitis Vaccine (Sabin strains)Biological
Also called Sabin IPV,lot No.20080303
15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Inactivated Poliomyelitis Vaccine (Sabin strains)Biological
Also called Sabin IPV, lot No.20080302
15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Inactivated Poliomyelitis Vaccine (Sabin strains)Biological
Also called Sabin IPV, lot No.20080301
15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Study groups in NCT01048190
Study group	Role	What they receive
Infants I-1	Experimental	Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart; Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Infants I-2	Experimental	15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart; Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Infant I-3	Experimental	15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart. Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Measured: one year

Secondary outcomes (1)

To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Mar 2009

First posted13 Jan 2010 (estimated)
Study startAug 2008
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PoliomyelitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01048190
Sponsor's protocol ID: imbcams-01
Other IDs: SFDA2007L02021
Acronym: IPV
Status last verified: Aug 2008
First submitted: 12 Jan 2010
Last updated: 14 Jan 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Poliomyelitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
ClinicalTrials.gov ID: NCT01048190
Acronym / sponsor ID: IPV / imbcams-01
Conditions: Poliomyelitis
Keywords: Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Chinese Academy of Medical SciencesUniversity, hospital or other
Collaborators: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control, National Institute for the Control of Pharmaceutical and Biological Products, China
Study start: Aug 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 13 Jan 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Infants I-1	Experimental	Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Infants I-2	Experimental	Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Infant I-3	Experimental	Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Who may qualify

Ages: 60 to 90 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Males and females, age from 60 days to 60 years old;
Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;

Key exclusion criteria (6 listed)

Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
Low platelet or bleeding disorder do not allow vaccination into the muscle;
Have damaged or lower immunological function;
Received blood, plasma or immunoglobulin treatment since birth;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inactivated Poliomyelitis Vaccine (Sabin strains)Also: Sabin IPV,lot No.2008030315 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.	Biological	Infants I-1
Inactivated Poliomyelitis Vaccine (Sabin strains)Also: Sabin IPV, lot No.2008030215 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;	Biological	Infants I-2
Inactivated Poliomyelitis Vaccine (Sabin strains)Also: Sabin IPV, lot No.2008030115 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.	Biological	Infant I-3

Primary outcome

To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time frame: one year

1 secondary outcome

To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
Time frame: one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Liao Guoyang, PhD principal investigator

Institute of Medical Biology, Chinese Academy of Medical Sciences

Li Rongcheng, MD principal investigator

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Li Changgui, PhD principal investigator

National Institute for the Control of Pharmaceutical and Biological Products, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inactivated Poliomyelitis Vaccine (Sabin strains) in people with Poliomyelitis, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01048190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.